CN106456183A - Occlusion device - Google Patents

Abstract

Provided herein is an occlusion device for intravesicular implantation and/or vascular occlusion, comprising: (a) a substantially solid marker having a proximal end and a distal end; and (b) a low-profile, elastic, mesh-like body attached to the distal end of the marker, the body having a delivery shape and a deployed shape, the deployed shape capable of conforming to the wall of the aneurysm; wherein the body has a diameter greater than the diameter of the aneurysm to be treated. Also provided herein are kits comprising the occlusion devices disclosed herein and components for delivering the occlusion devices. Methods of making and using the occlusion devices disclosed herein are also disclosed.

Description

Occlusive device

related application

This application claims priority to U.S. Provisional Application 61/986,369, filed April 30, 2014, and U.S. Provisional Application 61/083,672, filed November 24, 2014, the entire disclosures of which are hereby incorporated by reference. into this article. In addition, all documents and references cited herein and in the applications cited above are hereby incorporated by reference.

technical field

The present invention generally relates to the field of occlusive devices and/or occlusive device systems and/or implantable occlusive devices and their use for treating and/or alleviating aneurysms.

Background technique

There is a significant need for the development of improved occlusive devices and/or systems for treating and/or alleviating aneurysms. This observation is richly and widely supported by existing occlusion devices and/or systems currently in the field of aneurysm treatment. However, there remains an unmet need to provide treatment and/or mitigation of aneurysms, particularly neurovascular aneurysms, through occlusion devices constructed from a minimal amount of fully removable expandable material.

Aneurysms are known to form when a swollen portion of an artery is stretched thin by the pressure of blood. The weakened part of the artery forms a bulging or bulging area that is at risk of leaking and/or rupturing. When a neurovascular aneurysm ruptures, it causes bleeding into the chambers surrounding the brain, the subarachnoid space, resulting in a subarachnoid hemorrhage. Subarachnoid hemorrhage from ruptured neurovascular aneurysms can lead to hemorrhagic stroke, brain damage, and death. About 25% of all neurovascular aneurysm patients suffer from subarachnoid hemorrhage. Neurovascular aneurysms occur in 2% to 5% of the population and are more common in women than men. It is estimated that as many as 18 million people currently living in the United States will develop a neurovascular aneurysm during their lifetime. Each year, subarachnoid hemorrhage occurs in more than 30,000 people in the United States. Ten to 15 percent of these patients die before reaching the hospital, and more than 50 percent die within the first thirty days after rupture. Of those who survive, about half suffer some permanent neurological deficit.

Smoking, hypertension, traumatic head injury, alcohol abuse, use of hormonal contraception, family history of brain aneurysm, and other genetic disorders such as Ehlers-Danlos syndrome (EDS), polycystic kidney disease and Marfan syndrome may contribute to neurovascular aneurysms.

Most unruptured aneurysms are asymptomatic. Some people with unruptured aneurysms experience some or all of the following symptoms: peripheral vision deficits, thinking or processing problems, speech complications, perceptual problems, sudden changes in behavior, loss of balance and coordination, decreased concentration, short-term memory difficulties, and fatigue. Symptoms of a ruptured neurovascular aneurysm include nausea and vomiting, neck stiffness or pain, blurred or double vision, pain above and behind the eyes, dilated pupils, sensitivity to light, and loss of sensation. Sometimes patients who describe "the worst headache of my life" are experiencing one of the symptoms of a ruptured neurovascular aneurysm.

Most aneurysms remain undetected until they rupture. However, aneurysms can be discovered during routine medical examinations or diagnostic procedures for other health problems. The diagnosis of a ruptured brain aneurysm is usually made by finding signs of a subarachnoid hemorrhage on a CT scan (computerized tomography). If a CT scan is negative but a ruptured aneurysm is still suspected, a lumbar puncture is done to test for blood in the cerebrospinal fluid (CSF) that surrounds the brain and spinal cord.

To determine the exact location, size, and shape of the aneurysm, neuroradiologists use cerebral angiography or tomographic angiography. Cerebral angiography, this traditional procedure involves introducing a catheter into an artery (usually in the leg) and guiding it through the body's blood vessels to the artery involved in the aneurysm. A special dye called a contrast agent is injected into the patient's arteries, and its distribution is shown on an X-ray projection. This method may fail to detect some aneurysms due to overlapping structures or spasms.

Computed tomographic angiography (CTA) is an alternative to traditional methods that can be performed without the need for arterial cannulation. This test combines a conventional CT scan with contrast dye injected into a vein. Once the dye is injected into the vein, it travels to the arteries of the brain, and images are produced with a CT scan. These images show exactly how blood flows into the arteries of the brain. New diagnostic modalities promise to complement classical and conventional diagnostic studies with less invasive imaging and may provide more accurate 3-dimensional anatomical information relevant to aneurysm pathology. Better imaging, combined with the development of improved minimally invasive treatments, will allow physicians to increasingly detect and treat more occult aneurysms before they become a problem.

Several methods of treating aneurysms have been attempted with varying degrees of success. For example, a craniotomy is an extravascular procedure to locate and dispose of an aneurysm. This operation has significant disadvantages. For example, patients experience a great deal of trauma in the area of the aneurysm because the surgeon must cut through various tissues to reach the aneurysm. In extravascular treatment of a cerebral aneurysm, for example, the surgeon typically must remove part of the patient's skull and must also injure brain tissue to reach the aneurysm. Therefore, there is a possibility of epilepsy developing in the patient as a result of the surgery.

Other techniques for treating aneurysms are performed endovascularly. Such techniques typically involve attempting to form a mass within the aneurysm's sac. Typically, a microcatheter is used to access the aneurysm. The distal end of the microcatheter is placed within the sac of the aneurysm, and the microcatheter is used to inject embolic material into the sac of the aneurysm. Embolic materials include, for example, detachable coils or embolic agents, such as liquid polymers. The injection of these types of embolic material has disadvantages, most of which are related to the migration of embolic material out of the aneurysm into the parent artery. This can lead to permanent and irreversible occlusion of the parent artery.

For example, when a detachable coil is used to occlude an aneurysm that does not have a well-defined neck region, the detachable coil can migrate out of the sac of the aneurysm and into the parent artery. Also, when deploying a detachable coil, it is sometimes difficult to accurately measure how full the aneurysm sac is. Therefore, there is a risk of overfilling the aneurysm, in which case the detachable coil also protrudes into the parent artery.

Another disadvantage of snap-off coils relates to the compression of the coils over time. After filling the aneurysm, spaces remain between the coils. Ongoing hemodynamic forces from the circulation act to compress the coil mass, creating a cavity in the neck of the aneurysm. Therefore, the aneurysm can be recanalized.

Embolic agent migration is also a problem. For example, when a liquid polymer is injected into the sac of an aneurysm, the liquid polymer can migrate out of the sac of the aneurysm due to the hemodynamics of the system. This can also lead to irreversible occlusion of the mother duct.

Various techniques have been attempted to address the disadvantages associated with migration of embolic material into the parent vessel. Such techniques are, but are not limited to, temporary flow stagnation and parental occlusion, and generally involve temporary occlusion of the parental duct proximal to the aneurysm so that blood flow through the parental duct does not occur until thrombus has formed in the aneurysm's sac sex lumps. In theory, this helps reduce the tendency of embolic material to migrate out of the aneurysm sac. However, it has been found that thrombotic masses can be liquefied by the normal lysis of blood. Furthermore, even temporarily occluding the mother duct is highly undesirable from a patient risk/benefit perspective in certain circumstances. Therefore, this technique is sometimes not considered a treatment option. Furthermore, it is now known that even occlusion of the main duct may not prevent all embolic material from migrating into the main duct.

Another endovascular technique for treating aneurysms involves the insertion of a detachable balloon into the sac of the aneurysm using a microcatheter. The detachable balloon is then inflated with saline and/or contrast fluid. The balloon is then detached from the microcatheter and left within the aneurysmal sac in an attempt to fill the aneurysmal sac. However, detachable balloons also have disadvantages, so this method has been superseded by existing methods of deploying coils or other types of occlusive devices. For example, detachable balloons typically do not conform to the internal anatomy of the aneurysm sac when inflated. In contrast, detachable balloons require the aneurysm sac to conform to the outer surface of the detachable balloon. Therefore, a detachable balloon would increase the risk of rupture of the aneurysmal sac. In addition, detachable balloons can rupture and migrate out of the aneurysm.

Another endovascular technique for treating aneurysms involves an occlusion device with two expandable lobes and a waist, or an expandable body, neck and base.

Another endovascular technique for treating aneurysms involves occlusive devices for endovascular implantation having a body portion designed to radially fill and/or dilate into the intrasaccular space of the aneurysm.

尽管这些闭塞装置可见于例如美国专利号5,025,060；5,928,260；6,168,622；6,221,086；6,334,048；6,419,686；6,506,204；6,605,102；6,589,256；6,780,196；7,044,134；7,093,527；7,128,736；7,152,605；7,229,461；7,410,482；7,597,704；7,695,488；8,034,061；8,142,456； 8,261,648; 8,331,138; 8,430,012; 8,454,633; and 8,523,897; US application number 2003/0195553; 2004/0098027; 2006/0167494; 2007/0288083; 2011/0046658; 2012/028333333333333333333333333333333333333333333333333333333 ; European Application No. EP 1651117; and International Application No. WO13/109309; but none of these documents discloses an embodiment of the occlusive device disclosed herein.

Accordingly, the present invention provides new improvements and advantages in the field of vascular occlusions because the occlusion devices disclosed herein provide protection against aneurysms, particularly neurovascular occlusions, by using a minimal amount of fully removable deployable material. treatment and/or mitigation of aneurysms. The configuration of such an oversized occlusion device eliminates the need for additional material to be attached to the neck of the aneurysm, and/or the need for a fixation mechanism in the parent duct adjacent to the aneurysm, and/or makes the device The need for bulbous, radial expansion of the body into the sac of the aneurysm.

All documents and references cited herein and in the patent documents cited above are hereby incorporated by reference.

Contents of the invention

The inventors of the present invention have designed an occlusive device for providing aneurysm treatment and/or relief by using a minimal amount of fully removable, deployable, low-profile elastic mesh material that is critical to the aneurysm's The diameter is too large. As such, an occlusion device having less material than current standard devices minimizes the need for anticoagulation therapy and/or reduces the risk of clot formation that may flow deeper into the vascular tree, thereby inducing stroke. The implantable occlusive device is also useful in the treatment of vascular occlusion and/or peripheral vascular embolism.

Disclosed herein is an occlusion device for intrasaccular implantation, the occlusion device comprising: (a) a generally solid marker having a base end and a distal end; and (b) a low profile elastic mesh A body attached to an end of the marking portion, the body having a delivery shape and a deployed shape capable of conforming to the wall of the aneurysm; wherein the diameter of the body is larger than the diameter of the aneurysm to be treated.

In another embodiment, the elastic mesh of the occlusive device is a single layer mesh.

In another embodiment, the elastic mesh of the occlusive device is a double layer or two layer mesh. In a further embodiment, the double layer mesh comprises a single layer mesh folded circumferentially.

In another embodiment, the expanded shape of the elastic mesh of the occlusion device can be positioned opposite the roof of the aneurysm.

In another embodiment, the proximal end of the marker portion of the occlusion device is capable of sealing the neck of the aneurysm. In a further embodiment, the marker is a radiopaque marker, the marker is a detachable joint to enable deployment of the occluder device, the marker is an attachable joint to remove the occluder, the marker comprises a rigid member , and/or the marked portion is a solid ring.

Also disclosed herein is a kit comprising an occlusion device disclosed herein and a delivery component for deploying the occlusion device.

Also disclosed herein is an implantable device for vascular occlusion comprising: (a) a generally solid marker having a base end and a distal end; and (b) a low profile elastic mesh body that Attached to the end of the marking portion, the body has a delivery shape and a deployed shape capable of conforming to the wall of the blood vessel; wherein the diameter of the body is larger than the diameter of the blood vessel to be treated.

In another embodiment, the body of the occlusive device is a single layer mesh.

In another embodiment, the body of the occlusive device is a double layer or two layer mesh. In a further embodiment, the double layer mesh comprises a single layer mesh folded circumferentially.

Further disclosed herein is an implantable device for vascular occlusion comprising: (a) a generally solid marker having a base end and a distal end; and (b) an elastic mesh body attached to At the end of the marking portion, the body has a delivery shape and a deployed shape, the expanded shape is capable of conforming to the wall of the blood vessel; wherein the body is a double layer mesh including circumferential fold lines. In another embodiment, the elastic mesh body of the occlusive device is a low profile elastic mesh body.

Further disclosed herein is an occlusive device comprising: (a) a substantially solid marker having a base end and a distal end; and (b) an elastic mesh body attached to the distal end of the marker, the body having The delivery shape and the deployed shape, the deployed shape is capable of conforming to the wall of the blood vessel or the wall of the aneurysm; wherein the diameter of the body is larger than the diameter of the aneurysm or blood vessel to be treated; and the height of the body is about 10%-20% of the width of the body between.

Additionally disclosed herein are methods for manufacturing and/or delivering and/or deploying the occlusive devices disclosed herein.

In other embodiments, the occlusive device of the preceding paragraphs may comprise any of the preceding or subsequently disclosed embodiments.

This summary is not intended to limit the claims in any way, nor is it intended to limit the scope of the invention in any way.

Other features and advantages of the invention will become apparent from the following drawings, detailed description and claims.

Description of drawings

1A-1B illustrate perspective views of embodiments of occlusion devices disclosed herein. Figure 1A shows the diameter (x) of the occlusion device in free air. Figure IB shows a cross-sectional view of an occlusion device deployed in an aneurysm having a diameter (y).

2A-2C illustrate perspective views of delivery and/or deployment embodiments of the occlusion devices disclosed herein. Figure 2A shows the device in its delivery shape. Figure 2B shows the device being deployed in such a way that the compressed end of the mesh material opens outward. Figure 2C shows the device in its deployed shape.

3A-3B illustrate perspective views of embodiments of occlusive devices disclosed herein. Figure 3A shows the diameter (x) of an occlusive device with circumferential fold lines and a double or two layer of mesh material. Figure 3B shows a bilayer occlusion device disclosed herein deployed in an aneurysm having a diameter (y).

4A-4C illustrate perspective views of delivery and/or deployment embodiments of the occlusion devices disclosed herein. Figure 4A shows the bilayer occlusive device in its delivery shape. Figure 4B shows a bilayer occlusive device being deployed in such a way that the compressed end of the device opens outwardly. Figure 4C shows the flattening effect/increase in width/increase in diameter of the double layer/two layer mesh material of the device in the unfolded state.

5A-5B illustrate perspective views of electrolytic delivery and/or deployment and/or detachment embodiments of the occlusion devices disclosed herein. Figure 5A illustrates the delivery of a bilayer occlusive device using a catheter and/or guide wire with an electrolytic component. Figure 5B shows electrolytic separation of the core wire or guide wire from the occlusive device.

detailed description

The invention has been described in the drawings and description where like reference numerals refer to like elements. However, while specific embodiments are shown in the drawings, there is no intent to limit the invention to the specific embodiment or embodiments disclosed. Rather, the invention is intended to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention. As such, the drawings are intended to be illustrative, not restrictive.

Unless otherwise defined, all technical terms used herein have the same meanings as commonly understood by those skilled in the art.

Exemplary embodiments of the present invention are depicted in FIGS. 1-5 .

For the purposes of the present invention, the term "corresponding to" means that there is a functional and/or mechanical relationship between objects that correspond to each other. For example, the occlusive device delivery system corresponds to (or is compatible with) the occluder device for deployment of the occluder device.

For the purposes of the present invention, without limitation, the term "occlusive device" refers to terms such as "device" or "occlusive device system" or "occlusive system" or "system" or "occlusive device implant" or "implant " or " intrasaccular implant (intrasaccular implant) ", etc., and/or may be interchangeable with these terms.

Occlusive device delivery systems are well known and readily available in the art. For example, without limitation, such delivery techniques can be found in the following US patents and publications: 4,991,602; 5,067,489; 6,833,003; 2006/0167494; 2007/0288083; the teachings of each of which are incorporated herein. For the purposes of the present invention, any type of occlusive device delivery component and/or delivery system and/or delivery technique and/or delivery technique may be used and/or modified in a manner compatible with (corresponding to) the occlusive device disclosed herein. Mechanisms and/or separate (and/or attached) components and/or separate systems and/or separate techniques and/or separate mechanisms. Without limitation, exemplary occlusive device delivery mechanisms and/or systems include guide wires, push wires, catheters, microcatheters, and the like. Without limitation, exemplary occluder disengagement mechanisms include fluid pressure, electrolytic mechanisms, hydraulic mechanisms, interlock mechanisms, and the like. In one embodiment, an occlusion device disclosed herein is used in a method of electrolytic separation. Electrolytic separation is well known in the art and can be found, for example, in the following US patents: 5,122,136; 5,423,829; 5,624,449; 5,891,128; 6,123,714; 6,589,230; 6,620,152.

1A and 3A illustrate an embodiment of an occlusion device disclosed herein for intrasaccular implantation within an aneurysm 10 to be treated. Figures 1A and 3A also show the diameter (x) of the elastic mesh body 14 of the occlusive device in "free air". The diameter of the occlusive device was measured in free air as accepted in the art. Thus, for the purposes of the present invention, in one embodiment, the elastic mesh body 14 of the occlusive device is "oversized" relative to the aneurysm 10, thus as shown in FIGS. 1A and 1B and FIGS. 3A and 3B , the diameter (x) of the elastic mesh body 14 of the occlusive device is greater than the diameter (y) of the aneurysm 10 to be treated (that is, φx>φy); that is, the diameter (y) is the largest diameter of the aneurysm 10 to be treated , or a larger diameter of the aneurysm 10, as long as the mesh body 14 is oversized in a manner that sufficiently seals the neck 22 of the aneurysm 10 to trigger clot formation and/or cure. An exemplary range of diameter (x) for occlusion devices disclosed herein is approximately 6 millimeters (mm) to 30 millimeters (mm), and an exemplary diameter (y) of an aneurysm to be treated is less than the value of x. For example, the diameter (x) of the occlusive device is any of 7mm, 11mm and/or 14mm. In one embodiment, the location of the end 34 of the generally solid marker portion 16 is attached approximately equidistant from the opposite end of the elastic mesh 14 . This positioning of the marker portion 16 within the elastic mesh 14 within the capsule imparts full removability to the occlusion devices disclosed herein.

In another embodiment, the occlusion devices disclosed herein are "oversized" relative to any vessel to be treated, such as in pathological conditions where vascular occlusion is desired, eg, in peripheral vascular disease. In this example, the diameter (x) of the occlusion device is larger than the diameter (z) of any vessel to be treated so long as the body 14 of the occlusion device conforms to the vessel wall and promotes clot formation.

Figures IB and 3B illustrate an embodiment of an occlusion device disclosed herein deployed within an aneurysm 10 to be treated. Figures 1B and 3B show the diameter (y) of the aneurysm 10 to be treated, and also show the parent vessel 12 (and basilar artery) adjacent to the aneurysm 10 and its neck 22 Blood flow in (arrows). In one embodiment, the elastic mesh body 14 of the occlusive device is of a "low profile" configuration in free air and when deployed.

For the purposes of the present invention, the term "low profile" means that the height 32 of the elastic mesh 14 in free air is between about 10% and about 20% of its width, thus in the expanded shape of the elastic mesh 14. Bottom, the elastic mesh 14 is arranged to rush upward against the wall of the aneurysm 10 in a flattened manner, and the elastic mesh 14 is positioned to cover at least the inner surface of the lower portion 20 of the aneurysm 10 and seal the aneurysm 10 22 of the neck. In this manner, the occlusion devices disclosed herein are lower and/or elongated than readily available occlusion devices in the art that expand to fill the space of the dome of the aneurysm 10 (relative to the main dome in the aneurysm 10). space completely and/or partially filling the space of the roof of the aneurysm 10), and an occlusive device that expands radially and/or in a spherical manner. In one embodiment, the height 32 of the elastic mesh 14 is between about 12% and about 18% of its width in free air. In another embodiment, the height 32 of the elastic mesh 14 is between about 14% and about 16% of its width in free air. In another embodiment, the height 32 of the elastic mesh 14 is about 15% of its width in free air. In one embodiment, the expanded shape of the low-profile elastic mesh 14 covers from about 40% to about 80% of the interior surface area of the apex of the aneurysm 10 . In another embodiment, the expanded shape of the low-profile elastic mesh 14 covers from about 50% to about 70% of the interior surface area of the apex of the aneurysm 10 . In another embodiment, the expanded shape of the low profile elastic mesh 14 covers approximately 60% of the interior surface area of the apex of the aneurysm 10 .

In another embodiment, the low-profile winged and/or open-ended expansion configuration of body 14 is a single layer of elastic mesh material. In another embodiment, the low profile expanded construction is a double layer (or two layers) 24 of elastic mesh material. As noted above, the elastic mesh 14 is "oversized" compared to the aneurysm 10 to be treated; thus, the diameter (x) of the mesh 14 is greater than the diameter (y) of the aneurysm 10 to be treated (i.e., greater than the largest diameter of the aneurysm 10 to be treated, or a larger diameter, as long as the mesh 14 is oversized in a manner that sufficiently seals the neck 22 of the aneurysm 10 to trigger the aneurysm 10 clot formation and/or healing). The low-profile and oversized features of the elastic mesh body 14 give the elastic mesh body 14 the ability to conform (with opposing pressure of the body 14 against the wall of the aneurysm 10) to the inner surface of the wall of the aneurysm 10, thus The occlusive device extends along the wall of the aneurysm 10 only in at least the lower portion 20 of the aneurysm 10 (i.e., in a flattened manner with a smaller volume), thereby eliminating the need for attachment to the neck 22 and the aneurysm 10. and/or the need for the material to be secured within the mother tube 12 (thus minimizing the need for anticoagulation therapy). In this manner, the spanning and/or expanding body 14 conforms to the interior surface of the aneurysm 10 and is positioned opposite the apex of the aneurysm 10 . This configuration facilitates sealing the neck 22 of the aneurysm 10 and thus facilitates clot formation and/or healing and/or shrinkage of the aneurysm 10 if the size or mass of the aneurysm 10 is causing pain or other side effects to the patient. is particularly advantageous. This configuration is also advantageous because it requires a minimal amount of elastic mesh material, thereby eliminating the need to fill or substantially fill the space in the roof of the aneurysm 10 in a spherically radially expanding manner. The occlusion device is well suited to conform to a wide range of aneurysm 10 morphologies, particularly since it is well known and generally accepted that aneurysms 10 are not perfectly round. Because the occlusion devices disclosed herein have "minimal" or less material than current standard devices, the need for anticoagulation therapy is minimized, and/or the formation of clots that may flow deeper into the vascular tree to induce stroke is reduced. (clot emboli formation) risk, so it is also beneficial.

In another embodiment of the occlusive device disclosed herein, the single or double layer 24 of the elastic mesh material of the low profile device comprises a relatively even distribution of wire mesh strands or braids, not Limitingly, such as a 72-strand nickel-titanium alloy (NiTi) wire mesh strand braid construction. In other embodiments, the occlusive device comprises wire mesh strands or webbing ranging from a 36-strand NiTi wire weave configuration to a 144-strand NiTi wire weave configuration.

In another embodiment, as shown in FIGS. 3A-3B and 4A-4C, the double-layer 24 occlusive device disclosed herein is to fold the wire mesh circumferentially (along the circumferential fold line 26) and thereby make the wire The structure of the net folded in half. The ends of the double or double-folded layer 24 intersect the marker 16 located approximately at the core of the body 14 of the device. In this regard, the device is constructed by folding a single layer of wire material circumferentially at a preferred fold line 26, thereby effectively obtaining an occlusive device comprising a double layer 24 of wire mesh material, i.e. a double layer 24 of mesh comprising Single layer web folded circumferentially (along circumferential fold line 26). Without wishing to be bound by theory, in animal studies, the two or bilayers 24 of the mesh material triggered a mechanism of action believed to contribute to substantially enhanced thrombogenicity of the device. It is believed that the nucleation and stabilization of the thrombus is facilitated by positioning a small volume clot between the double/double layer 24, which has a high surface area contributed from the mesh threads. In the deployed shape, the body 14 with the reentrant bilayer 24 is deeper when compared to an undeployed bilayer 24 occlusion device due to approximately 15% of the width when pressure is applied at the marker 16 This width translates into an increase in the diameter (x) of the device. Since blood will exert pressure on the mesh 14 distributed across the neck 22 of the aneurysm 10, this change in width/increase in diameter (x) is an effective fixation property of the deployed device. This configuration also provides for adequate abutment of the body 14 of the device against the wall of the aneurysm 10 or vessel for peripheral arterial or venous occlusion. Based on the animal studies to date, it is clear that the devices disclosed herein provide sufficient mesh density to impart substantial stasis. Based on analysis of the post-deployment device, it is further known that the wire mesh/webbing distribution remains relatively uniform.

FIGS. 1B and 4B also show the position of the marking portion 16 having a base end 36 and a distal end 34 on the occlusion device of the present invention. The end 34 of the marker 16 is attached to the elastic mesh 14 of the occlusion device. The base end 36 of the marker 16 is shown resting across the neck 22 of the aneurysm 10 to be treated in a bridge-like mechanism when combined with the properties of the low profile elastic mesh 14 , eliminates the need to include additional material for attachment to the neck 22 of the aneurysm 10 and/or as a fixation within the mother tube 12, and advantageously provides complete removability of the device.

In one embodiment, the marker portion 16 of the occlusive devices disclosed herein is a substantially solid collar or rigid member, such as, without limitation, a solid ring formed from, without limitation, gold, platinum, Stainless steel, and/or combinations thereof, etc. In another embodiment, radiopaque materials such as, without limitation, gold, platinum, platinum/iridium alloys, and/or combinations thereof, etc., can be used. This marker 16 provides visualization of the device during delivery and placement. The marker 16 is positioned within the occlusion device such that the base end 36 of the marker 16 can be positioned above the neck 22 of the aneurysm 10 . The solidity of the marking portion 16 contributes to the stability of the administration device within the aneurysm 10 and prevents movement or force transmission through the elastic mesh 14, thereby preventing misplacement or accidental movement of the device. The marking portion 16 is also configured with a coupling portion for mating with and detaching from/attaching to a corresponding delivery component, such as, without limitation, a delivery catheter or guide wire and/or pusher Line (pusher wire) 18 technology etc. The complete removability of the devices disclosed herein is also advantageously provided.

In another embodiment, the substantially solid marker portion 16 comprises a radiopaque material (such as, without limitation, platinum, gold, platinum/iridium alloys, and/or combinations thereof, etc.) The period facilitates visualization of the occlusive device under fluorescence detection. The marker portion 16 includes a base end 36 and a distal end 34 . The elastic mesh 14 is attached to the distal end 34, and the base end 36 of the marker portion 16 may be configured to affect the shape, diameter and/or curvature of the elastic mesh 14 as the occlusive device expands. The markers 16 can be designed in various shapes to affect the overall profile of the occlusion device to ensure proper fit of the expanded/deployed occlusion device within the sac of the aneurysm 10 .

2A-2C and 4A-4C illustrate exemplary components for delivering and/or deploying an occlusion device disclosed herein through an artery 12 and/or blood vessel adjacent an aneurysm 10 . In one embodiment, as shown in FIGS. 2A and 4A , the occlusive device is delivered via a push wire mechanism 18 in a closed compressed configuration (delivery shape) with the low profile body 14 closed or compressed inwardly upon itself. . When the device is pushed and/or placed into the sac of the aneurysm 10, the ends of the low-profile elastic mesh body 14 open outward in a flower-blossom pattern (as shown in Figures 2B and 4B), and then the open body 14 conforms to the wall of the aneurysm 10, thereby allowing the marker portion 16 to be supported across the neck 22, the low-profile body 14 is arranged to expand in a flattened manner (expanded shape) to cover at least the lower portion 20 of the aneurysm 10, and to seal The neck 20 of the aneurysm 10 . In one embodiment, as shown in FIGS. 2C and 4C , the device shows darkening and/or flattening of a single layer ( FIG. 2C ) or double layer 24 ( FIG. 4C ) device due to The width of the device changes and the diameter (x) increases when pressure is applied at 16. Since blood will exert pressure on the body 14 distributed across the neck 22 of the aneurysm 10, this change in width/increase in diameter (x) is an effective fixation property of the deployed device. The results of the animal studies presented herein support that, for peripheral arterial or venous occlusion, the circumferentially doubled/double layered 24 configuration provides adequate abutment of the mesh body 14 of the device to the wall or vessel of the aneurysm 10 .

5A-5B illustrate exemplary components for electrolytically delivering and/or deploying and/or detaching an occlusion device disclosed herein through an artery 12 and/or blood vessel adjacent an aneurysm 10 . Electrolytic detachment means and methods such as US Patent No. 5,122,136 are well known in the art. In one embodiment, the coil-wound core wire (or guide wire) 28 of the catheter (or microcatheter) is attached within the marker 16 at the end 34 of the marker 16 to the double layer 24 disclosed herein. The occlusive device (as shown in Figure 5A). The coil winding maintains a constant diameter (φ) so as not to affect the flexibility or rigidity of the delivery catheter, microcatheter or guide wire. In a particular embodiment, FEP (fluorinated ethylene propylene) heat shrink tubing surrounds the coil wrap 28 of the core wire. Attaching the end of the core wire within the marker band 16 and attaching the end of the core wire to the occlusion device or implant can be done using a number of readily available and well known attachment techniques in the medical device arts. Without limitation, these attachment techniques include adhesives, laser melting, laser tack, spot welding, and/or continuous welding. In one embodiment, an adhesive is used to attach the ends of the core wires within the marker tape 16 . In a further embodiment, the adhesive is an epoxy material that is cured or hardened by the application of heat or UV (ultraviolet) radiation. In a still further embodiment, the epoxy is such as available from Epoxy Technology, Inc., 14 Fortune Drive, Billerica, Mass. 353ND-4 and other heat-cured two-component epoxy. The adhesive or epoxy material encapsulates the joints of the core wires in the marking tape, thereby improving the mechanical stability of the core wires.

In another embodiment, upon and/or after device deployment, the coil-wound core wire 28 contacts the occlusive device of the double layer 24 disclosed herein at the electrolytic separation site (region) 30 of the core wire itself in the following manner: Separation (as shown in FIG. 5B ): The core wires are separated and/or dissolved at the base of the marker tape 16 by electrolysis. This action then releases and/or places the bilayer 24 occlusive device into the aneurysm or vessel to be treated.

In particular embodiments, the low-profile elastic mesh body 14 of the occlusive devices disclosed herein may be filled with embolic material to facilitate coagulation and closure of the aneurysm 10 .

In other embodiments, the oversized occlusive devices disclosed herein may further include additional elements and/or components such as coiling technology, frame coils, embolic agents, additional markers, polymers, absorbent polymers, and / or a combination thereof.

Resilient mesh materials for use in the design and/or manufacture of occlusive devices are readily available and known to those skilled in the relevant art. Accordingly, the range of resilient mesh materials is a variety of useful materials such as, but not limited to, nickel titanium (nitinol or otherwise known as NiTi), stainless steel, polymers, and/or combinations thereof. Exemplary known families of biomedical polymers include, but are not limited to, polymers such as polyphosphazenes, polyanhydrides, polyacetals, poly(orthoesters), polyphosphates, polycaprolactones, polyurethanes, polylactides , polycarbonate, polyamide and/or combinations thereof. (See, eg, J Polym Sci B PolymPhys. Author's manuscript; Accessed from PMC, 15 June 2012)

In an exemplary embodiment, the elastic mesh material is formed from braided strands of a polymeric material, such as, but not limited to, nylon, polypropylene, or polyester. The polymeric strands may be filled with a radiopaque material that allows a physician treating the aneurysm to fluoroscopically visualize the location of the device within the vasculature. The radiopaque filler preferably comprises bismuth trioxide, tungsten, titanium dioxide or barium sulfate, or a radiopaque dye such as iodine. The elastic mesh material may be formed from strands of radiopaque material. The radiopaque strands allow the physician and/or radiologist to fluoroscopically view the mesh location without the use of filled polymeric materials. Such radiopaque strands may be formed from materials such as, but not limited to, gold, platinum, platinum/iridium alloys, and/or combinations thereof. In one embodiment, the elastic mesh material is composed of 10%-20% platinum core NiTi. In another embodiment, the elastic mesh material is composed of 10% platinum core NiTi, 15% platinum core NiTi or 20% platinum core NiTi. A 10% platinum core NiTi structure is sufficient to provide ghosting of the occlusion device under x-ray.

Composite or composite wires of this construction having a radiopaque core and a non-radiopaque outer layer or sheath are readily available and are well known in the medical device and metal arts, e.g. (drawn filler tube) wire, cable or ribbon. Wire is a metal-metal composite material constructed to combine the desired physical and mechanical properties of two or more materials into a single wire. By placing a more radiopaque, but more ductile material in the core of the wire, the NiTi outer layer can provide the resulting composite wire with mechanical properties similar to 100% NiTi wire. Wire is available from Wayne Metals Corp., Fort Wayne, Ind., USA. See also, eg, the journal article entitled "Biocompatibility Line" by Schaffer in Advanced Materials & Processes, October 2002, pp. 51-54, which is hereby incorporated by reference.

Where the elastic mesh material is formed from radiopaque metal strands, the strands may be covered by a polymer coating or extrusion. Coating or extrusion on the radiopaque wire strands provides fluorescent visualization, but also increases the resistance of the strands to bending fatigue and can also increase the lubricity of the strands. In one embodiment, the polymeric coating or extrusion is coated or treated with an agent prone to anticoagulation, such as heparin. Such anticondensation coatings are well known. The polymer coating or extrusion can be any suitable extrudable polymer, or any polymer that can be applied as a thin coating, such as or polyurethane.

In yet another embodiment, the strands of elastic mesh material are formed using both metal and polymer braided strands. Combining the metal strands with the polymer strands into a webbing changes the flexible properties of the mesh. The force required to expand and/or retract a mesh portion comprising only strands of the metal mesh is significantly reduced compared to the force required to expand and/or retract such a mesh portion. However, the radiopaque properties of the mesh used for fluorescence visualization were preserved. Metal strands forming such devices include, but are not limited to, stainless steel, gold, platinum, platinum/iridium, nitinol, and/or combinations thereof. The polymeric strands forming the device may include nylon, polypropylene, polyester, and/or combinations thereof. In addition, the polymeric strands of the mesh material can be chemically modified using known techniques to render them radiopaque, such as, but not limited to, by using gold deposited onto the polymeric strands, or by applying ion beam plasma to suitably The metal ions deposited on the polymer strands.

The elastic mesh material can also be formed from filaments or strands of different diameters and/or different flexibility. By varying the size or flexibility of the polymeric strands, the flexibility characteristics of the web when deployed can also be varied. By varying the flexible properties, the expanded and contracted configurations of the elastic mesh 14 can be varied or changed into substantially any desired shape.

Meshes can be formed not only from polymeric strands or filaments and metal strands or filaments, but also using filaments of different polymeric materials. For example, different polymeric materials with different flexibility properties can be used to form the web. This changes the flexibility characteristics, thereby changing the resulting configuration of the mesh body 14 in the expanded and retracted positions. Such biomedical polymers are known and available in the art and may be derived from polymer families such as, but not limited to, polyphosphazenes, polyanhydrides, polyacetals, poly(orthoesters), polyphosphoric acids Esters, polycaprolactones, polyurethanes, polylactides, polycarbonates, polyamides, and/or combinations thereof.

A resilient mesh material suitable for use within mesh body 14 may take the form of a flat fabric sheet, a knitted sheet, or a laser cut mesh. Typically, the material should comprise two or more sets of generally parallel strands, wherein one set of parallel strands is at an inclination angle of between 45 degrees and 135 degrees relative to the other set of parallel strands. In some embodiments, the two sets of parallel strands forming the mesh material are substantially perpendicular to each other. The inclination and general structure of the mesh material can be optimized to meet the performance needs of the occlusive device.

The tows of metal fabric used in the present invention should be formed from a material that is elastic and can be heat treated to generally set the desired shape. Materials considered suitable for this purpose include those known in the field of occlusive devices as Cobalt-based low thermal expansion alloys available commercially from Haynes International under the trade name Nickel-based high-temperature, high-strength "superalloys" produced by International Nickel under the trade name Nickel-based heat-treatable alloys are sold, as well as many different grades of stainless steel. An important factor in selecting a suitable material for the wire is that the wire retains an appropriate amount of deformation (or shape memory as described below) induced by the forming surface when subjected to a predetermined heat treatment.

One class of materials that fulfill these conditions are so-called shape memory alloys. Such alloys tend to have a temperature-induced phase transition that will result in a material with a preferred configuration that can be fixed by heating the material above a certain transition temperature to induce a phase change in the material. As the alloy cools, the alloy will "remember" its shape during heat treatment and will tend to assume the same and/or similar configuration unless forced otherwise.

One particular shape memory alloy for use in the present invention is nitinol, which is an approximately stoichiometric alloy of nickel and titanium, which may also include other minor amounts of other metals to achieve the desired properties. NiTi alloys, such as nickel-titanium alloys, including suitable compositions and processing requirements, are well known in the art, and such alloys need not be discussed in detail here. For example, US Patent Nos. 5,067,489 and 4,991,602, the teachings of which are incorporated herein by reference, discuss the use of shape memory NiTi alloys in wire-based technologies. Such NiTi alloys are preferred, at least in part, because they are commercially available and more is known about processing such alloys than other known shape memory alloys. NiTi alloys are also very elastic. In fact, they're called "hyperelastic" or "pseudoelastic." This resiliency will assist the occlusive device disclosed herein to return to its previous expanded configuration, allowing it to deploy.

The tow may comprise standard monofilaments of selected materials, ie standard wire stocks may be used. In some embodiments, a 72 tow and/or 72 strand braid structure may be used. In other embodiments, the occlusive device comprises wire mesh strands or webbing ranging from 36 to 144 NiTi strand braided configurations. However, if desired, individual harnesses may be formed from "cables" comprised of a plurality of individual wires. For example, cables formed from filaments in which multiple filaments are helically wound around a central filament are commercially available, and NiTi cables can be purchased with an outer diameter of 0.003 inches or less. One advantage of certain cables is that they tend to be "softer" than monofilament wires of the same diameter and formed from the same material. Additionally, the use of cables increases the effective surface area of the tow, which will help promote thrombus formation.

The closure devices disclosed herein are configured as a low-profile elastic mesh material with a mesh density sufficient to function in such a way as to act as a scaffold for endothelial cells within the vessel or across the neck 22 of the aneurysm 10, thereby reducing blood flow by about 60%. % to trigger clot formation and/or healing of the aneurysm 10. For the purposes of the present invention, the term "mesh density" refers to the level of porosity or ratio of metal to open area of the mesh body 14 . Mesh density relates to the number and size of the openings or pores of the mesh, and the degree to which the pores open or close as the openings or pore openings vary between delivery and deployment. Typically, the high mesh density regions of the resilient mesh material have approximately more than about 40% metallic areas and less than about 60% open areas.

In some embodiments, elastic mesh 14 may be uniformly formed from the same material; however, such material may have different knit, stitch, webbing, and/or cut configurations.

In other embodiments, the implantable occlusive devices disclosed herein are useful, for example, in the treatment and/or alleviation of peripheral arterial or venous disease and/or any associated condition for which vascular occlusion is required for the treatment thereof ( Processes involving shutting off blood flow away from a given blood vessel point are well known and known in the art).

The occluder device of the present invention may incorporate reasonable design parameters, features, modifications, advantages and variations that will be apparent to those skilled in the art in the field of occluder devices.

Example

Study protocols and adjustments for animals were reviewed and approved by the ISIS Service Institutional Animal Care and Use Committee (IACUC), and procedures were performed under veterinary supervision.

The rabbit elastase aneurysm model is a widely accepted and art-recognized model for testing new neurointerventional devices and has been the subject of numerous clinical publications regarding efficacy and similarity of response to humans. (See eg Altes et al., Creation of Saccular Aneurysms in the Rabbit: A Model Suitable for Testing Endovascular Devices. AJR 2000; 174:349-354.) It is therefore readily accepted by regulatory agencies as an appropriate testing model. The model's coagulation system is very similar to that of humans. Furthermore, this model has favorable anatomical aspects, as the diameter of the extracranial carotid artery in rabbits is very similar to that of humans. Furthermore, elastase-induced aneurysms have been shown to behave in a histologically similar manner to human aneurysms.

Example I

Non-detachable occlusion device lot number 30680, detachable occlusion device lot number 30676, aneurysm size 4.5 millimeters (mm) (height) x 2.5 width

A 5-F (5-French) sheath was placed in the femoral artery through which a 0.035" lumen, 65 centimeter (cm) length 5F Cordis catheter and a 0.035" Terumo guidewire channel were advanced into the carotid artery.

With the aneurysm neck as a marker, a non-removable occlusion device was placed in the aneurysm and contrast runs were made at timed intervals. Immediately after deployment of the device a good position in the aneurysm was observed, with some slowing of flow. Five minutes after deployment, some stasis was observed in the aneurysm. Ten minutes after deployment, further stagnation in the aneurysm was observed and the device was reset closer to the aneurysm neck. Fifteen minutes after deployment, flow stagnation in the aneurysm was observed. When the device was removed from the aneurysm and heparin was administered, the flow to the aneurysm returned to the pre-deployment state.

The non-removable occlusion device was then removed and the 7 mm diameter occlusion device was advanced into a 0.027" lumen microcatheter (Excelsior XT27, Stryker) using a 0.014" guide wire channel (Synchro2, Stryker). Note that the advancement of the device in the catheter is smooth with low friction. The occlusive device is advanced to the neck of the aneurysm and deployed. Timed angiography was performed. Stasis of flow in the aneurysm was observed immediately after deployment. Five minutes after deployment, a filling defect in the aneurysm was observed. Ten minutes after deployment, the thrombus in the aneurysm was observed. 20 minutes after deployment, the 5F catheter was removed. After completion of the procedure, animals were euthanized according to Standard Operating Procedure (SOP).

Example II

Non-detachable occlusion device lot number 30680, detachable occlusion device lot number 30676, aneurysm size 10mm high x 4mm wide x 3mm neck

A procedure similar to Example 1 was performed, but with a non-detachable device placed into the neck of the aneurysm. In this example, the 4F system was used to introduce the device into a 5F sheath, and it was noted that "stepping on" the inner hub of the catheter resulted in device capture. The device was placed and timed angiograms were obtained as previously described. Some flow reduction in the aneurysm was observed immediately after deployment. Five minutes after deployment, a filling defect was observed in the aneurysm sac. Ten minutes after unfolding, an increase in the size of the filling defect was observed.

The device was removed, angiography showed that flow in the aneurysm had returned to the pre-deployment state, and the implantable (disconnected) device was deployed using the same method as before. The implant initially required some force to transition from the loading sheath into the microcatheter (probably due to poor compatibility of the sheath with the hub lumen), but once inserted, the microcatheter advanced freely.

Note that the device has reasonable deployment control despite not being secured to the breakaway mechanism. Positioning over the neck of the aneurysm was achieved and timed angiography runs obtained. Thrombosis of the distal portion of the aneurysm was observed immediately after deployment. 5 minutes after deployment, actual occlusion of the aneurysm sac was observed. 10 minutes after deployment, complete occlusion of the aneurysm sac was observed. Fifteen minutes after deployment, occlusion of the aneurysm distal to the device marker was observed.

On angiography 5 minutes after deployment, the activated clotting time (ACT) was found to be twice normal. The blood pressure of the animals was normal (85/55, mean 60-65 mm hg) throughout the procedure. The positioning of the device in the animal allows for stasis without damage to the underlying carotid artery, so live animals will be reassessed 30 days after the study.

Example III

Detachable device lot number 30676, aneurysm size 6.5mm x 3.1mm wide x 2.4mm neck

The procedure followed the same protocol as in Example II, however, at the time of contrast injection, it was noted that the aorta had been dissected. The device can be deployed into the neck of the aneurysm and a timed angiogram obtained as previously described.

observe

This series of angiograms demonstrates that the mesh webbing configuration of the occlusion device disclosed herein is dense enough to reduce blood flow in the aneurysm, resulting in blood pooling and thrombus formation in the aneurysm sac. This study, taking into account the variation in animal morphology, enables an understanding and consideration of device development and its deployment techniques.

All femoral punctures were performed through the femoral incision with a vein picker. The sheath used was 5-F and specifically had a very narrow tip that allowed expansion of the femoral vessel without damaging it. Catheter length is an issue, especially in devices that are fixed on wires. Therefore, in all cases, a shortened/manually cut catheter is used. This means that the distal catheter tip is rather sharp and protruding, causing problems similar to vessel dissection in Example III. Nevertheless, this can be solved by using a micro-sheath, and the deployment of the occlusive device (through a large guide catheter) is smooth and corresponds to the use of devices with a detachment mechanism.

Steering and deployment control of the occlusion device was performed while visualizing the proximal radiopaque marker of the device relative to the catheter tip. Device development will need to incorporate radiopaque supports of platinum-cored NiTi wires to help improve visibility.

Expansion of the occlusive device in animal studies was limited (7 mm). Device development will include increased diameters greater than 7 mm. Accordingly, such devices have been designed with diameters of 11 mm and 14 mm. Even so, all deployments promote stasis in the aneurysm despite limitations in expansion of the 7mm device, and all devices are amenable to highly precise manipulation, especially with regard to guidance through the parent artery and the neck of the aneurysm, as well as transarterial The neck of the aneurysm is placed within the aneurysm.

A number of embodiments of the invention have been described. Reasonable features, modifications, advantages and design variations of the claimed apparatus will be apparent to those skilled in the art by following the references set forth in the foregoing detailed description and embodiments without departing from the scope and spirit of the invention. Obvious. Accordingly, other implementations are within the scope of the following claims.

Claims (25)

CLAIMS 1. An occlusion device for intrasaccular implantation comprising: (a) a generally solid marker having a base end and a distal end; and (b) a low profile elastic mesh a body, the low-profile elastic mesh body attached to the end of the marking portion, the body has a delivery shape and a deployed shape, the deployed shape can conform to the wall of the aneurysm; wherein the diameter of the body larger than the diameter of the aneurysm to be treated. 2. The occlusive device of claim 1 wherein said body is a single layer mesh. 3. The occlusive device of claim 1 wherein said body is a double layer mesh. 4. The occlusive device of claim 3, wherein the double layer mesh comprises a single layer mesh folded circumferentially. 5. The occlusive device of claim 1, wherein the body has a deployed shape capable of being positioned opposite the apex of the aneurysm. 6. The occlusion device according to claim 1, wherein the base end of the marking part can seal the neck of the aneurysm. 7. The occlusion device of claim 1, wherein the marker is a radiopaque marker. 8. The occlusive device of claim 1, wherein the marking portion is a detachable link to allow deployment of the occlusive device. 9. The occlusive device of claim 1, wherein the marking portion is an attachable link for removal of the occlusive device. 10. The occlusive device of claim 1, wherein the marking portion comprises a rigid member. 11. The occlusive device of claim 1, wherein the marking portion is a solid ring. 12. A kit for treating and/or alleviating an aneurysm; said kit comprising: a. An occlusive device for intrasaccular implantation comprising (i) a substantially solid marker having a base end and a distal end; and (ii) a low profile elastic mesh body, the A low profile elastic mesh body is attached to the end of the marking portion, the body has a delivery shape and a deployed shape capable of conforming to the wall of the aneurysm; wherein the body has a diameter larger than that to be treated the diameter of the aneurysm; and b. A delivery system or separation system corresponding to said occlusive device. 13. The kit of claim 10, wherein the delivery system is a microcatheter, catheter, guide wire or push wire. 14. The kit of claim 10, wherein the separation system is an electrolytic separation system. 15. A method for treating or alleviating an aneurysm in a patient, said method comprising: a. Delivery of an occlusive device for intrasaccular implantation to an aneurysm, wherein the device comprises (a) a generally solid marker having a base end and a distal end; and (b) a low profile elastic mesh A low-profile elastic mesh-like body attached to the end of the marker, the body having a delivery shape and a deployed shape capable of conforming to the wall of the aneurysm; wherein the body greater than the diameter of the aneurysm to be treated; and b. Deploying the occlusion device in the aneurysm, thereby treating or alleviating the aneurysm in the patient. 16. An implantable device for vascular occlusion, the implantable device comprising: (a) a generally solid marker having a base end and a distal end; and (b) a low profile elastic mesh A low-profile elastic mesh-like body attached to the end of the marking portion, the body having a delivery shape and a deployed shape capable of conforming to the wall of a blood vessel; wherein the body's The diameter is greater than the diameter of the blood vessel to be treated. 17. The implantable device of claim 16, wherein the body is a single layer mesh. 18. The implantable device of claim 16, wherein the body is a double layer mesh. 19. The implantable device of claim 18, wherein the double layer mesh comprises a single layer mesh folded circumferentially. 20. An implantable device for vascular occlusion, the implantable device comprising: (a) a substantially solid marker having a base end and a distal end; and (b) an elastic mesh body , the elastic mesh body is attached to the end of the marking part, the body has a delivery shape and a deployed shape, and the deployed shape is capable of conforming to the wall of the blood vessel; wherein the body is a double layer net. 21. The implantable device of claim 20, wherein the elastic mesh body is a low profile elastic mesh body. 22. An occlusive device comprising: (a) a substantially solid marker having a base end and a distal end; and (b) an elastic mesh body attached to the elastic mesh body Attached to the end of the marking portion, the body has a delivery shape and a deployed shape capable of conforming to the wall of the blood vessel or the wall of the aneurysm; wherein the diameter of the body is larger than the diameter of the aneurysm or blood vessel to be treated diameter; and the height of the body is between about 10%-20% of the width of the body. 23. The occlusive device of claim 22, wherein the height of the body is between about 12%-18% of the width of the body. 24. The occlusive device of claim 22, wherein the height of the body is between about 14%-16% of the width of the body. 25. The occlusive device of claim 22, wherein the height of the body is about 15% of the width of the body.